Diagnostic and therapeutic apparatus



G. I YFORD DIAGNOSTIC AND THERAPEUTIC APPARATUS Filed June 11, 1937 ma ww WN Il kunt@ ll uw.

May 2, 1939.

1 N VEN TOR. Giona-'5 yf-'opa ATTORNEYS.

Patented May 2', 1939 UNITED STATE` PATENT OFFICE DIAGNOSTICl AND THERAPEUTIC APPARATUS 6 Claims.

My invention relates to diagnostic and therapeutic apparatus and more particularly to apparatus for procuring essential data in the differential diagnosis of pelvic pathology in the female.

During the past fteen years during which trans-uterine insuiilation has been increasingly used for the study of the Fallopian tubes, much Work has been done and a great deal has been Written concerning its diagnostic value, its dangers and its use as a therapeutic agent. Theoretically, at least, it would seem that this practice could also be used for studies of the normal physiology and this has to some extent been attempted. Many diiiiculties have been encountered in connection with such studies and in connection With such treatments which have greatly impeded progress. One of these diiilculties has been the inaccuracy of the apparatus. This has beenperhaps the chief hindrance, although another diificulty of almost equal importance has been the discomfort to the patient resulting from the insufation.

In view of the above mentioned diiiiculties it is an object of my invention to provide an apparatus for such studies and treatments as outlined above which will be extremely accurate and which will be simple and reliable in operation. Another object of my invention is to provide an apparatus which will be readily portable and which will be substantially automatic and foolprooi in its operation.

These and other objects of my invention which will be described hereinafter or which Will be apparent to one skilled in the art upon reading these specifications, I accomplish by that certain construction and arrangement of parts of which I shall now describe an exemplary embodiment. Reference is now made to the drawing which forms a part hereof and in which:

Figure 1 is a diagrammatic representation of the apparatus showing the'electrical connections.

Fig. 2 is a detail cross sectional view oi an oil cartridge, useful in connection with my apparatus.

Fig. 3 is a diagrammatic representation of an arrangement for indicating Whether right or left or both tubes have opened.

Brieily in the practice of my invention, I provide means for building up pressure in a reservoir; I provide means for applying pressure to the patient and for indicating or recording the pressure which is applied to the patient; I provide means for causing the pressure to by-pass (Cl. 12S-2) the patient; and in connection with these means I provide electrical means for by-passing the patient automatically when a predetermined maximum pressure is attained or when there is a drop in pressure, such as would be encountered as 5 a result of the opening of a Fallopian tube.

Referring to Fig. 1 I have indicated an electric motor at I which drives a reciprocating pump 2. The pump 2 is connected by a line 3 provided with a ball-check valve 4 and a lter 5 to a reser- 10 voir 6. The reservoir 6 is preferably provided With an indicating device 'I for indicating the pressure within the reservoir. A line 8 leads from the pressure reservoir to other parts of the apparatus as will be described hereinafter and is provided with a pin-point orifice 9, whereby there is a slow leakage of gas through the line 8 under pressure from the reservoir 6. The line I communicating with the line 8 leads to the patient and in use is attached to a uterine canula. The 20 line I I, which is in parallel with the line III, leads to a conventional bellows pressure indicating device I2 which actuates a stylus I3. The stylus I3 is adapted to trace a recording line upon a chart driven by a synchronous motor in a con- 25 ventional manner. It will thus be seen that the stylus I3 at all times indicates the pressure to which the patient is being subjected. Ahead of the junction between the line 8 and the lines I@ and I I, I provide a by-pass line I4 leading to 9,730 valve I5. Thus when the valve I5 is open manifestly no pressure will be applied to the patient and when the valve I5 is closed the pressure the line 8 operates upon the patient through the line I0 and upon the stylus through the line II. 35 The Valve I5 comprises a housing I6 in which there is an entrance port I'I and a discharge port I8. A plunger I9, upon which is mounted the closing member 2D, fits in a bore in the housing I6 and the Valve is closed When the member 40 223 abuts the seat portion 2|. The valve plunger is actuated by a lever 22 pivoted at 23 and connected at one end to the plunger I9. A solenoid 213, when energized, operates to close the Valve.

For indicating purposes I may provide an arrangement of red and green lights connected as shown. The end of the lever 22 carries a contact member 25 which is adapted to make contact with the contact member 26 when the valve is closed and with the member 2'I when the valve is 50 opened. I prefer to use six-volt red and green lights and, therefore, place in the line a stepdown transformer 28. The intensity of illumination of light may be adjusted by the rheostat 29. From the above description it will be clear that when the solenoid is energized to close the valve and cause pressure to be applied to the patient the red light will be illuminated and that when the valve is opened so that the patient is bypassed, the green light will be illuminated.

The maximum pressure device comprises a plate 39 pivoted at 3l, preferably on the panel and adapted to be turned by a knob on the control panel of the apparatus. The plate 30 is connected by means of a lever 32 to a pointer 33, which cooperates with a calibrated scale so that the position of the plate 3U may be adjusted to any predetermined desirable maximum pressure. The plate 30 carries a iixed contact member 34 and a resiliently mounted contact member 35, whereby the electrical contact between the members 34 and 35 is normally closed. It will thus be clear that assuming a circuit through the leads 36, 31, 38 and a source of electrical energy that the circuit will be broken when the member 35 is moved away from contact with the member 34. It will also be clear that the point at which the contact between the members 34 and 35 will be broken depends upon the angular position of the plate 30 upon which the contact members are mounted.

The stylus I3 carries a contact member 39 which is adapted to make contact, shortly after the stylus has begun to move from its zero position, with a pivoted contact member 40. The member 40 is arranged so that in its minimum position it is out of contact with the member 39 -when the stylus is at zero. The member 40 is resiliently mounted in any conventional manner so that as soon as the stylus has begun to move and has made contact with the members 39 and 40, this contact will be maintained as long as the pressure is increased or remains static. As soon as there is a decrease in pressure, the electrical contact between members 39 and 40 will be broken.

I will now proceed with a description of the electrical connections to the device. The power lead 4I is connected to one element 42 of a control. The other lead 43 is connected to the motor I and to the solenoid 24 by means of the leads 44 and 38 respectively. A lead 31, as above described, connects the other side of the sole noid 24 with the member 35 and the member 34 is connected by means of the lead 36 to a switch element 45. The switch element 46 is connected by means of a lead 41 to the motor I and the switch element 48 is connected by means of a lead 49 to the contact bar 39 on the stylus I3. A lead 5U connects the contact member 4U with the lead 35. It is to be noted that in accordance with this diagram, the switch member 48 is normally closed, while the switch members 45 and 46 are normally open.

The procedure in using this apparatus will now be described. The uterine canula at the end of the lead IU is placed in or through the cervix with the usual technique for insuiilations using surgical care for antisepsis. The patient is then placed in a slightly Trendelenburg position and the vagina filled with a mild antiseptic solution making a water seal. The canula is connected with the apparatus by means of the conventional Luer fittings. If a switch is provided in the lines 4I or 43, such switch is first closed in order to supply current to the apparatus and the rheostat 29 is adjusted to provide the desired intensity of illumination of the indicating lights. If desired the indicator 1 and the indicator 33 are also made visible by illuminated dials and,

of course, means may be provided for regulating the degree of intensity of illumination of these dials. The motor operating the recording chart, which has not been described because it is conventional, is then set into operation, and if the stylus is provided with a raising iinger as is conventional, this must be lowered so that the stylus contacts the chart for recording. The indicator 33 is then adjusted to the maximum pressure beyond which it is not desired to have the apparatus operate for any particular patient.

The control comprising the members 42, 45, 46 and 48 may, of course, be mounted upon the control panel of the apparatus. However, I prefer to incorporate them in a remote control hand switch so that `the operator may move about and still retain perfect control of the apparatus. The next step is to close the switch member 46, whereby a circuit is established through the line 4I, the members 42 and 46, the line 41, the motor I, and the lines 44 .and 43, and the motor I is thus set into operation and pressure will be built up in the reservoir 6. The pressure which is being built up in the reservoir 6 will not be applied to the patient because the valve I5 is open and the patient is thus by-passed. Now, if the switch member 45 is closed a circuit is established through the line 4I, the members 42 and 45, the line 36, the contact members 34 and 35, the line 31 and through the solenoid 24 to the lines 38 and 43. Thus the solenoid 24 is energized and closes the valve I5. At this point the green light goes off and the red light comes on, indicating that the patient is being subjected to pressure.

As soon as the stylus I3 has moved a small distance in accordance with the increase of pressure applied to the patient, a holding circuit is completed through the line 4I, the member y42, the normally closed switch 48, the line 49, the contact members 39 andf4, the lines 50 and 36, the line 31, the solenoid 24 and the lines 38 and 4I. It will be clear that assoon as the contact between the members 39 and 40 has been made, the switch member 45 may be opened and the solenoid will continue to be energized through the last described circuit. 'Ihe switch member 46 need not be kept on continuously ybecause pressure is built up in the reservoir 6 faster than it is passed on to the patient so that the member 46 is preferably a push-button type of switch which may be intermittently actuated to .keep the pointer on the indicator 1 at a desired position.

As the stylus I3 moves toward the right pushing with it the member 49, it reaches the point where the member 49 will `abut a projecting portion 35a of the contact member 35 and will break the contact `between the members 34 and 35. As was before described, the point at which this contact break occurs may be determined by slight rotations of the plate 39. As soon as the Contact 34, 35 is broken, the solenoid 24 is .deenergized and the valve I5 .opens immediately exhausting the patient.

If, before the preset maximum pressure is attained, either or both of the Fallopian tubes opens, there will-obviously .be an immediate vdrop in pressure and concurrently the stylus I3 will immediately move toward the left breaking the contact between the members 39 land 49. Now, since the member 45 was opened as soon as contact has been established between the members 39 and 49, the solenoid 24 is again deenergized, the valve opens and the patient is immediately exhausted. By these means, discomfort to the patient is almost completely avoided. It may be noted here that leakage around the canula is, vof course, noted by bubbling through the water seal,

or by a flashing on of the green light indicatingeither that the stylus i3 has not been caused to rise suiiciently to make the contact 35, 55,' or that having risen and made contact, it has dropped back due to the leak.

The filter 5, previously referred to, is a conventional filter desirable for removing bacteria, moisture and the like from the-air. If carbon dioxide is used for the insuiflation (its use is sometimes desirable because it is readily absorbed by the system) a tank of carbon dioxide may be connected into the lter at 5a. In connection with the use of a carbon dioxide tank, a reducing valve must be placed between the table and filter because the pressure in the tank is too high. For roentgenological purposes, it is necessary to render the Fallopian tubes opaque. For this purpose I have provided an accessory which is shown in some detail in Fig. 2. This comprises a brass cylinder 5I threaded at both ends and containing a glass cylinder 52. The member 5l preferably has a cut-out portion 5m so that the interior of the cartridge may be observed. In my exemplary device I have threaded a Luer fitting 53 onto the entrance end of the member 5l by means of a threaded flange 54. At the exit end I simply place a Luer fitting 55 over the glass cylinder and clamp it firmly in place by means of the apertured clamping ange 56. Before screwing the member 54 in place, I insert within the cylinder a rubber diaphragm 51 with the edges thereof turned over the rim of the glass cylinder 52. The rubber member is firmly clamped in place by means of the member 54. The portion of the cartridge outside of the rubber member 5l is filled with oil as indicated at 58. From this description it will be clear that if pressure is applied through the entrance fitting 53, the rubber member 51 is inflated and the oil 58 within the cartridge is forced out through the fitting 55, which may be directly or indirectly attached to the canula. Instead of the glass cylinder and brass shell, I may of course use a cylinder made of any material, opaque or not, whereby the construction issimplified, and possibility of breakage eliminated.

I have found that by virtue of the ease of control and adaptability of the apparatus herein described, an entire set of graphs can be made and checked in fifteen minutes or less with little or no discomfort to the patient. I have found that the recording apparatus as checked against a manometer has an accuracy within one-half of one per cent and that the volume requiredhas never exceeded 25 cc. Although there may be occasional discomfort in the region of an opening tube, it is of extremely short duration relieved by the substantially instantaneous exhausting of the apparatus and is rarely followed by subphrenic referred pain, which though of diagnostic value, is not absolutely necessary. I have found that patients do not need to rest following an insufflation and are able to continue their activities immediately.

. tween the canula and the line l and the maxi mum pressure control is raised approximately 150 mm. above insufilation opening (this figure is the approximate oil resistance and can be obtained in any given instance by determining at what pressure oil starts flowing through the canula before its insertion into the uterus). The gas pressureis then gradually increased as with insuiliation, the oil noted under the fluoroscope asit enters the uterus and tubes, and the lms made as indicated. The iiuoroscopy and films can be checked with the graphic record in the chart. My usual procedure is to follow the insuiiiation immediately withY the former .procedure without moving the patient from the table. Roentgenological findings are of paramount importance and unless contra-indicated, should always be carried out for diagnoses, although not always necessary in follow-up therapy.

I may also surround the reservoir 5 with heating coils (not shown). in any desired way, and thereby heat the gas to any desired temperature. By then attaching an inflatable member to the tube i0, and inserting the latter in the'vagina or other body cavity, I may give heat therapy. This type of treatment is well known in medical practice, and I merely wish to point out the adaptability of my apparatus for such work.

In Fig. 3 I have shown diagrammatically means for determining whether the right or the left tube has opened. The numerals 6B and 5i represent respectively right and left microphones adapted ,to be held in position on the patients abdomen in the region of the Fallopian tubes. An amplifier is shown at t2, in which the feeble current generated in the microphone by the sound of an opening tube is amplified to a degree to enable it to operate a visual or audible signal for the right or left sides respectively, as indicated at 53 and 54.

Of course the amplified current may be made to actuate a recording needle in addition to the visual or audible signal, as is well known in the art, for the purpose of making a permanent record as to which tube opened.

It will be understood that modifications in my apparatus may be made without departing from the spirit of my invention and that I do not intend to limit myself otherwise than as pointed out in the claims which follow. v

Having now fully described my invention, what I claim as new and desire to secure by Letters Patent is:

1. A diagnostic and therapeutic apparatus for the purposes described, comprising means for producing pressure, means for storingv pressure, means for applying said pressure gradually to a patient, and means for automatically discontinuing the pressure on the patient upon the relief of an obstruction to said pressure within the patient.

2. A diagnostic and therapeutic apparatus for the purposes described, comprising means for producing pressure, means for storing pressure, means for applying said pressure gradually to a patient, and means automatically operative to discontinue the pressure on the patient immediately upon the relief of an obstruction to the pressure within the patient, or upon attainment of a predetermined maximum pressure upon vthe patient.

3. A diagnostic and therapeutic apparatus for the purposes described, comprising means for producing pressure, means for storing pressure, means for applying said pressure gradually to a patient, means for recording and indicating the pressure to which the patient is being subjected, and means operative automatically upon the relief of an obstruction to said pressure within the patient, or upon the attainment of a predetermined maximum pressure within the patient, for

immediately discontinuing :the pressure on the patient.

4. A diagnostic and therapeutic apparatus for the purposes described, comprising means for producing pressure, means for storing pressure, means for applying said pressure gradually to a patient, means for recording and indicating the pressure to which Vthe patient is being subjected, means operative automatically upon the relief of an obstruction to said pressure within the'patient, or upon attainment of a predetermined maximum pressure, for immediately discontinuing the pressure on the patient, and signal `means indicating whether or not pressure is -being applied to the patient.

5. A diagnostic and therapeutic apparatus for the purposes described, comprising means for producing pressure, means for storing pressure, means for applying said pressure vgradually to a patient, means for recording and indicating the pressure to which the patient is being subjected, means operative automatically upon the relief of an obstruction to said pressure Within the patient, or upon attainment of a predetermined maximum pressure, for immediately discontinuing the pressure on the patient, and signal means indicating Whether or not pressure is being applied to the patient and remote control means for said apparatus.

6. A method of treating pelvic pathology involving stricture of the Fallopian tubes in the female, which vincludes vthe steps of subjecting said tubes toa gradually increasing pressure, and causing the attainment of a predetermined maximum pressure, or the opening of one or both of the tubes, to automatically discontinue the pressure on the tubes.

GEORGE LYFORD. 

